OBJECTIVE:

To evaluate the effect of neonatal vitamin A supplementation on infant mortality, morbidity and early adverse effects.

DESIGN:

Systematic review, meta-analysis, and meta-regression of randomised controlled trials.

DATA SOURCES:

Electronic databases and hand search of reviews; abstracts and proceedings of conferences. Review methods Randomised or quasi-randomised or cluster randomised, placebo controlled trials evaluating the effect of prophylactic, neonatal (<1 month) supplementation with synthetic vitamin A on mortality or morbidity within infancy (<1 year), and early adverse effects (</=7 days).

RESULTS:

The six included trials were from developing countries. There was no convincing evidence of a reduced risk of mortality during infancy (relative risk 0.92, 95% confidence interval 0.75 to 1.12, P=0.393 random effect; I(2)=54.1%) or of an increase in early adverse effects including bulging fontanelle (1.16, 0.81 to 1.65, P=0.418; I(2)=65.3%). No variable emerged as a significant predictor of mortality, but data for important risk groups (high maternal night blindness prevalence and low birth weights) were restricted. Limited data (from one to four trials) did not indicate a reduced risk of mortality during the neonatal period (0.90, 0.75 to 1.08, P=0.270; I(2)=0%), cause specific mortality, common morbidities (diarrhoea and others), and admission to hospital. There was, however, evidence of an increased risk of acute respiratory infection and a reduced risk of clinic visits.

CONCLUSIONS:

There is no convincing evidence of a reduced risk of mortality and possibly morbidity or of increased early adverse effects after neonatal supplementation with vitamin A. There is thus no justification for initiating such supplementation as a public health intervention in developing countries for reducing infant mortality and morbidity.